Testing of pharmacopoeial ethanol (disinfectant ethanol)

disinfectant ethanol

Ethanol has antimicrobial properties and is sold as a disinfectant product at optimized concentrations. Quality control of alcohol as a medical product is carried out through verification testing methods stipulated by various pharmacopoeias. As part of an agreement, the procedures for verification testing of ethanol or anhydrous ethanol in disinfectants are roughly the same in the Japanese (JP), United States (USP) and European (EP) pharmacopoeias.

Verification test – component identification via the infra-red absorption spectrum

In the verification testing of ethanol and anhydrous ethanol, identification of components is carried out using Fourier transform infra-red spectrophotometer(FT-IR). Reference spectra are compared with the spectra of the target compounds. The Japanese Pharmacopeia (JP) specifies a liquid membrane technique test, and below is a measurement example of ethanol and anhydrous ethanol using a liquid cell (KRS-5 window disk).

the infra-red absorption spectrum

Purity test – analysis of volatile impurities

Volatile impurities in ethanol are detected with a gas chromatograph (GC). Methanol, acetaldehyde, acetal, benzene, etc. are checked as impurities. An appropriate instrument configuration is required to detect the specified 2 vol ppm limit of trace benzene and obtain good separation for acetaldehyde and methanol (separation of 1.5 or higher). The testing of disinfectant ethanol is covered under the general protocol for purity testing of ethanol.

 

Volatile impurities in ethanol are detected with a gas chromatograph

Example analysis of volatile impurities in ethanol

UV absorbance test – impurity analysis

The absorbance spectrum of an ethanol sample is used to test for the presence of impurities. A UV-Vis spectrophotometer is used at a wavelength range of 235-340 nm with water as a reference sample. The absorbance at three points (240 nm, 250-260 nm, 270-340nm) is checked as being below certain tolerance values (0.40, 0.30, and 0.10 respectively).

UV absorbance test

    240nm 250-260nm 270-340nm
File name Overall evaluation Absorbance Evaluation Absorbance Evaluation Absorbance Evaluation
disinfectant_ethanol.vspd Pass 0.124 Pass 0.052 Pass 0.016 Pass
FTIR Spectroscopy

FTIR Spectrophotometer

Despite their small footprint, smaller than an A3 size sheet of paper, these models have been engineered with a wide sample compartment that accommodates existing accessories from Shimadzu and other manufacturers. This capability makes them the smallest (installation footprint) and lightest FTIR spectrophotometers in the world that can be used with optional products from other manufacturers.

Gas Chromatography

Gas Chromatograph

Nexis GC-2030, Shimadzu's premier gas chromatograph, offers a modern approach to a classic chromatographic technique. Designed with the user in mind, new innovative features, exceptional performance and high-throughput capabilities will elevate your lab to the next level.

UV-Vis Spectrophotometer

UV-Vis Spectrophotometer

The UV-1900i is a double-beam UV-Vis Spectrophotometer using Shimadzu's original LO-RAY-LIGH diffraction grating technology. This instrument can not only run checks for nine JIS items, but also those stipulated in the Japanese Pharmacopoeia (JP), United States Pharmacopeia (USP), and the European Pharmacopoeia (EP).

For Research Use Only. Not for use in diagnostic procedures.

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